NCT07409675

Brief Summary

This is a single-center, single visit study conducted in healthy female subjects, aged 20 to 75 years inclusive meeting specific inclusion/exclusion criteria. The study is to develop a clinical photographic atlas to assess skin aging by studying the relationship between age, sun exposure and quantity of collagen measured non-invasively (LC-OCT). No product will be tested during the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

January 26, 2026

Last Update Submit

February 6, 2026

Conditions

Keywords

skin agingcollagenLC-OCT

Outcome Measures

Primary Outcomes (1)

  • Non-invasive tissue imaging: 3D imaging through Line-field Confocal Optical Coherence Tomography technology (LC-OCT) acquisitions

    Line-field Confocal Optical Coherence Tomography technology (LC-OCT) provides a unique 3D imaging modality, allowing the user to switch from a histology-like vertical mode to confocal-like horizontal mode and to record a 3D stack of tissue volumes in situ. With this technique skin can be imaged in vivo in its native state without further preparation. The superficial dermis can be clearly imaged using a live vertical, live horizontal and 3D mode. This assessment will be performed on the face (forehead) with the LC-OCT deepLive™ (DAMAE). This non invasive image will helps to characterize and quantify new metrics of skin aging linked to the dermal fibers network (collagen and elastin) such as caracterisation of the density and length of dermis fibers during aging.

    Day 1

Secondary Outcomes (3)

  • Standardized photographs of the face (front and 45° left and right sides)

    Day 1

  • Photo shooting

    Day 1

  • Questionnaire

    Day 1

Study Arms (5)

Group 1: 20-30 years

The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.

Diagnostic Test: LC-OCT acquisitions on the foreheadDevice: Perform standardized photographs using ColorFaceDevice: LC-OCT acquisitions on foreheadDevice: Perform photo-shooting using smartphones

Group 2: 31-40 years

The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.

Diagnostic Test: LC-OCT acquisitions on the foreheadDevice: Perform standardized photographs using ColorFaceDevice: LC-OCT acquisitions on foreheadDevice: Perform photo-shooting using smartphones

Group 3: 41-50 years

The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.

Diagnostic Test: LC-OCT acquisitions on the foreheadDevice: Perform standardized photographs using ColorFaceDevice: LC-OCT acquisitions on foreheadDevice: Perform photo-shooting using smartphones

Group 4: 51-60 years

The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.

Diagnostic Test: LC-OCT acquisitions on the foreheadDevice: Perform standardized photographs using ColorFaceDevice: LC-OCT acquisitions on foreheadDevice: Perform photo-shooting using smartphones

Group 5: 61-75 years

The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.

Diagnostic Test: LC-OCT acquisitions on the foreheadDevice: Perform standardized photographs using ColorFaceDevice: LC-OCT acquisitions on foreheadDevice: Perform photo-shooting using smartphones

Interventions

During the study visit, the investigator will for each subjects in Group 1: \- Perform standardized photographs using the ColorFace Group 2: \- Perform standardized photographs using the ColorFace Group 3: \- Perform standardized photographs using the ColorFace Group 4: * Perform standardized photographs using the ColorFace * Perform LC-OCT acquisitions on the forehead Group 5: * Perform standardized photographs using the ColorFace®; * Perform LC-OCT acquisitions on the forehead

Group 1: 20-30 yearsGroup 2: 31-40 yearsGroup 3: 41-50 yearsGroup 4: 51-60 yearsGroup 5: 61-75 years

Photographs

Group 1: 20-30 yearsGroup 2: 31-40 yearsGroup 3: 41-50 yearsGroup 4: 51-60 yearsGroup 5: 61-75 years

Image acquisition

Group 1: 20-30 yearsGroup 2: 31-40 yearsGroup 3: 41-50 yearsGroup 4: 51-60 yearsGroup 5: 61-75 years

photo from back and front camera pictures and selfie

Group 1: 20-30 yearsGroup 2: 31-40 yearsGroup 3: 41-50 yearsGroup 4: 51-60 yearsGroup 5: 61-75 years

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy female volunteers

You may qualify if:

  • Subject having signed an Informed Consent Form (ICF) before any trial related activity is carried out;
  • Healthy female subject aged 20 to 75 years inclusive at the time of signing the ICF;
  • Subject with a phototype I to III on Fitzpatrick's scale;
  • Subject who is willing to follow the study procedures and to complete the study course;
  • Subject registered with Social Security in agreement with French law on study research.

You may not qualify if:

  • Male subject;
  • Female subject who is pregnant or who is breast feeding;
  • Subject with current participation in any other interventional clinical study, based on interview of the subject;
  • Subject with facial dermatitis, rosacea, acne, eczema, psoriasis, skin rashes, open lesions, vitiligo or viral conditions such as herpes labialis;
  • Subject who has collagen vascular disease, a significant systemic disease, immunological problems or inflammatory skin conditions on the face;
  • Subject who has had a face lift;
  • Subject has had a non-ablative and/or ablative laser procedure on the face in the past 3 months;
  • Subject with a history of botulinum toxin or mesotherapy injections on the face within the last 6 months, or absorbable fillers injections (such as hyaluronic acid or autologous fat…) in the last 12 months or injectable implants (semi-permanent fillers) within the last 24 months;
  • Subject having done a moderate to deep peeling or non-invasive rejuvenation techniques such as radiofrequency, ultrasound and lasers in the last 6 months;
  • Subject having applied any cosmetic product (care cream, lotion, makeup) except usual cleansing products or any drug to her face on the day of the visit;
  • Subject who has been deprived of their freedom by administrative or legal decision, or who is under care of a guardian or legal guardianship, or subject hospitalized in a medical or social establishment for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPCAD, Hôpital l'Archet 2

Nice, 06000, France

Location

Study Officials

  • Catherine QUEILLE-ROUSSEL, MD

    CPCAD, Hôpital l'Archet 2

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 13, 2026

Study Start

November 6, 2024

Primary Completion

February 19, 2025

Study Completion

February 19, 2025

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations